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Set for a game-changing March
We continue to believe the INITIUM study will be positive, and see the readout in March as potentially game-changing for the company. We reiterate our BUY and NOK200 target price.
We continue to believe the data readout for INITIUM will be positive. We still estimate ‘phase success’ of 65% and LOA of 30% ahead of the data readout, well above average probability rates for comparable trials at this stage (DiMasi et al (2010), Wong et al (2019) and Hay et al. (2014)). Comparisons of the timeline with historical controls such as CheckMate 67 and CheckMate 511 support our view that patients receiving UV1 are likely to have deferred disease progression. We underline that comparisons with historical controls should always be made with caution and we continue to highlight two other explanatory factors for why it is taking longer than estimated for INITIUM patients to experience disease progression (or death): 1) the hospitals may be better than before at providing the patients with the comparator drug combination (without UV1); or 2) the patient selection in the INITIUM trial may have an overweight of relatively less-advanced patients (despite comparable inclusion/exclusion criteria).
Based on our recent discussions with oncologists, key opinion leaders and experts in the field, we find that in recent years the hospitals may have improved at coping with side effects from checkpoint inhibitors, although we hear no clear indications of a significant improvement in progression-free survival of the comparator arm. The main concern highlighted among experts for UV1 not having an effect is the second explanatory factor, an overweight of relatively less-advanced patients. As the INITIUM trial was partly conducted during the Covid pandemic, a possible effect on patient selection has been discussed (both delayed diagnosis and treatment, and therefore patients being more advanced, and hospitals prioritising relatively less-advanced patients, with severe patients not able to travel to hospitals). However, based on our understanding from key opinion leaders, recruitment in comparable studies was done following normal routines without notable changes in either direction. This does not mean that we can rule out the possibility of a comparably relatively less-advanced patient population in the INITIUM trial, but it supports our confidence for a positive outcome.
Q4 results. Operating expenses were NOK59.6m, and cash and cash equivalents were NOK266.6m at end-Q4. We see an expected financial runway through H2 2024.
BUY and NOK200 target price reiterated. We see the March readout as potentially game-changing for Ultimovacs. In the event of a positive INITIUM trial, we estimate (probability-adjusted) a deal with a partner in Q1 2025.